Re­al-world da­ta (RWD) and re­al-world ev­i­dence (RWE) are no longer emerg­ing con­cepts: They are foun­da­tion­al tools re­shap­ing how life sci­ences com­pa­nies un­der­stand dis­ease, eval­u­ate treat­ments and bring in­no­va­tion to mar­ket.

Yet, with­out stan­dard­ized, re­search-ready da­ta and a col­lab­o­ra­tive, an­a­lyt­i­cal­ly rig­or­ous part­ner, in­sights are of­ten shal­low and/or slow to ma­te­ri­al­ize. On the flip side, RWD and the in­sights it de­liv­ers have the po­ten­tial to im­prove health­care de­liv­ery and qual­i­ty while en­sur­ing med­ical in­no­va­tions reach the right pa­tients at the right time.

While few ques­tion the val­ue of re­al-world da­ta and ev­i­dence, the re­al­i­ty is that not all da­ta de­liv­ers the same lev­el of in­sight.

When or­ga­ni­za­tions mix and match datasets with­out un­der­stand­ing their po­ten­tial or lim­i­ta­tions, they risk over­look­ing the lon­gi­tu­di­nal and ac­tion­able el­e­ments that make ev­i­dence mean­ing­ful. Un­cer­tain­ty about which da­ta types are most com­pelling can lead to find­ings that feel in­com­plete — yield­ing few­er rel­e­vant, time­ly take­aways to sup­port re­search, en­sure com­pli­ance and in­form so­lu­tions that meet un­chart­ed pa­tient needs.

This is why the right ex­per­tise mat­ters. Turn­ing re­al-world com­plex­i­ty in­to re­al-world im­pact re­quires more than ac­cess to da­ta: It de­mands the ex­per­tise to in­ter­pret it, con­nect the dots and un­cov­er in­sights that move the nee­dle. Pre­mier com­bines rich da­ta with deep clin­i­cal and op­er­a­tional ex­pe­ri­ence, cre­at­ing a frame­work for RWD/RWE that dri­ves sig­nif­i­cant ad­vance­ments in re­search and de­vel­op­ment.

As one of the most com­pre­hen­sive elec­tron­ic health­care da­ta repos­i­to­ries, the Pre­mier Health­care Data­base (PHD) in­te­grates clin­i­cal and qual­i­ty datasets for deep in­sights. Un­like most health­care data­bas­es, the PHD al­so in­cludes charge­mas­ter da­ta. When paired with claims da­ta, this da­ta set — the largest of its kind in the coun­try — iden­ti­fies every de­vice and drug used, de­liv­er­ing es­sen­tial con­text to in­form the de­ci­sion-mak­ing process.

RWD/RWE can po­ten­tial­ly help life sci­ences com­pa­nies:

• Ad­dress the grow­ing de­mand for da­ta to demon­strate ef­fi­ca­cy and safe­ty.
• An­a­lyze mar­ket dy­nam­ics and in­form strate­gies to max­i­mize fu­ture sales.
• In­form de­vice de­vel­op­ment with crit­i­cal da­ta on drug and de­vice per­for­mance and safe­ty, en­sur­ing high stan­dards in di­verse set­tings.
• Dif­fer­en­ti­ate prod­ucts in a “sea of same­ness” com­pet­i­tive land­scape.
• As­sess ther­a­peu­tic in­ter­ven­tions not stud­ied in ran­dom­ized clin­i­cal tri­als (RCTs).
• Com­plete To­tal Cost of Care (TCOC) as­sess­ments.
• Sup­port and stream­line reg­u­la­to­ry sub­mis­sions and ap­provals.

Ad­vance­ments in RWD have forged an un­prece­dent­ed op­por­tu­ni­ty to use RWE across near­ly every seg­ment of the health­care ecosys­tem. From eval­u­at­ing treat­ment out­comes and mar­ket dy­nam­ics to guid­ing clin­i­cal care and in­no­vat­ing tri­al de­sign, RWE turns re­al-world da­ta in­to ac­tion­able in­sights.

The fol­low­ing are sev­en ex­am­ples of how RWE is dri­ving smarter de­ci­sions, im­prov­ing pa­tient care and ac­cel­er­at­ing in­no­va­tion across the prod­uct life­cy­cle.

1. Out­comes re­search eval­u­ates the end re­sults of ther­a­peu­tic treat­ments on the health­care sys­tem and process­es of care for pa­tients and pop­u­la­tions.
2. Mar­ket analy­sis de­ter­mines the prod­ucts or treat­ments for a giv­en dis­ease state high­light­ing pa­tient, vis­it and site char­ac­ter­is­tics.
3. Com­par­a­tive ef­fec­tive­ness mea­sures the ef­fi­ca­cy of mul­ti­ple ther­a­peu­tic in­ter­ven­tions in­clud­ing out­comes, safe­ty and harms.
4. Mar­ket trend­ing re­views re­al-world up­take of prod­ucts in the mar­ket and/or com­pares up­take vs. com­pet­i­tive prod­ucts.
5. Post-mar­ket sur­veil­lance hap­pens af­ter a med­ical prod­uct is ap­proved and mar­ket­ed. RWE can give life sci­ences com­pa­nies crit­i­cal in­sight in­to the safe­ty and ef­fec­tive­ness of their prod­uct as it per­forms in a re­al-world set­ting. It can al­so ex­pand com­pa­nies’ un­der­stand­ing of a prod­uct’s val­ue in re­la­tion to care and high­light off-la­bel use and ef­fec­tive­ness.
6. For­mu­la­tion of clin­i­cal care guide­lines can de­rive ev­i­dence from com­par­ing out­comes among dif­fer­ent pop­u­la­tions or for dif­fer­ent treat­ments among a more uni­form pop­u­la­tion.
7. Clin­i­cal stud­ies and tri­als man­i­fest mul­ti­ple ap­pli­ca­tions for RWE in­formed by RWD. RWE can com­ple­ment tra­di­tion­al clin­i­cal tri­als by pro­vid­ing da­ta about a broad­er and more di­verse pa­tient group, fill­ing in gaps for re­searchers, clin­i­cians and part­ners. It can en­able de­cen­tral­ized clin­i­cal tri­als and the use of syn­thet­ic con­trol arms (SCAs) to po­ten­tial­ly re­place or sup­ple­ment tra­di­tion­al con­trol groups. It can al­so pro­vide da­ta that might not oth­er­wise be avail­able, such as pa­tient-gen­er­at­ed da­ta. RWE can even serve as a use­ful tool in pre-tri­al study de­sign, help­ing re­searchers iden­ti­fy po­ten­tial par­tic­i­pants.

Pre­mier’s ex­ten­sive provider net­work and deep re­la­tion­ships across the U.S. health­care sys­tem de­liv­er a ground-lev­el, re­al-time un­der­stand­ing of clin­i­cal prac­tice. Com­bined with strate­gic al­liances, ad­vanced an­a­lyt­ics and mul­ti­dis­ci­pli­nary ex­per­tise span­ning clin­i­cians and da­ta sci­en­tists, this ecosys­tem cre­ates a pow­er­ful frame­work for gen­er­at­ing mean­ing­ful RWE.

Tele­flex, a glob­al provider of med­ical tech­nolo­gies, part­nered with Pre­mier to gen­er­ate a ro­bust RWE pack­age for a high-risk im­plantable de­vice, nav­i­gat­ing chal­lenges con­cern­ing de­vice vis­i­bil­i­ty, trace­abil­i­ty and long-term track­ing. Lever­ag­ing the PHD, the com­pa­ny built well-sub­stan­ti­at­ed ev­i­dence de­signed to align with reg­u­la­to­ry ex­pec­ta­tions and re­flect RWE per­for­mance.

“It’s been an ex­cel­lent use case for us in terms of get­ting our foot in­to the re­al-world ev­i­dence realm and show­ing Tele­flex (in­ter­nal stake­hold­ers) the val­ue of RWE,” said Trevor Car­den, Di­rec­tor of Sci­en­tif­ic Af­fairs at Tele­flex.

In an era when da­ta vol­ume con­tin­ues to ex­pand and speed to val­ue grows in im­por­tance, dis­cern­ment mat­ters more than ever. The or­ga­ni­za­tions that suc­ceed will be those that rec­og­nize not all da­ta is equal — and who har­ness the right da­ta, an­a­lyt­ics and ex­per­tise to turn re­al-world com­plex­i­ty in­to re­al-world im­pact.

Learn more about Pre­mier Ap­plied Sci­ences, the re­search di­vi­sion of Pre­mier, and how you can use the gold-stan­dard PHD to un­lock pow­er­ful in­sights.

Last fall, the FDA launched what it called an ag­gres­sive crack­down on phar­ma ad­ver­tis­ing, send­ing drug­mak­ers thou­sands of let­ters de­mand­ing that they re­move mis­lead­ing con­sumer ads.

Months lat­er, the phar­ma in­dus­try is still spend­ing hun­dreds of mil­lions of dol­lars on ads.

Di­rect-to-con­sumer drug ad spend changed lit­tle in the three months af­ter the FDA made its an­nounce­ment on Sept. 9, ac­cord­ing to es­ti­mates from Me­di­aRadar, which tracks pre­scrip­tion drug ad spend­ing across tele­vi­sion, dig­i­tal, ra­dio and oth­er chan­nels. Month­ly spend rose from $817 mil­lion in Sep­tem­ber to about $842 mil­lion in No­vem­ber, be­fore dip­ping slight­ly to about $833 mil­lion in De­cem­ber. That’s more than the $736 mil­lion the in­dus­try spent in De­cem­ber 2024.